James R. Margolis, M.D., F.A.C.C.
Independent Consultant
Dr. Margolis is the pioneer of angioplasty in the Southeastern United States and the sixth person in the World to perform coronary angioplasty. He is a leading physician and director of cardiovascular research and education at the Miami International Cardiology Consultants in Miami, Florida. He is American Board certified in Internal Medicine, Interventional Cardiology and Cardiovascular Disease. Dr. Margolis has been published in more than one hundred medical publications and peer-reviewed journals, including the Journal of the American Medical Association, Circulation, The American Heart Journal, Catheterization and Cardiovascular Interventions, Annals of Vascular Surgery and the Journal of Interventional Cardiology. He has lectured and performed live case presentation on five continents, and for the past 24 years has directed the globally recognized “International Symposium of Interventional Cardiology.” Dr. Margolis received his M.D. from the University of Illinois Medical School. Dr. Margolis is an independent consultant for CPC and has served as a principal investigator in the company’s clinical studies.
Fred L. Ma, M.D., Ph. D.
Medical Monitor
Dr. Ma has more than 25 years of clinical experience as a board-certified neurosurgeon, and as an executive in pharmaceutical and medical device companies. As a former executive for Johnson & Johnson, Cell Pathways and Gliatech, he has led the successful development and commercialization of more than 20 new drugs and medical devices. Dr. Ma is founder, president and CEO of medical consulting company, Medical Quality International, LLC. He earned an M.D. from Capital University of Medical Sciences in Beijing, a D.M.Sc. from Tokyo University, Japan, and a Ph.D. in pharmacy from Rutgers University. Dr. Ma serves as the Medical Monitor for CPC of America, Inc., providing services through Medical Quality International, LLC. Headquartered in Cleveland, Ohio, Medical Quality International, LLC (MQI) is an international consulting and business development company founded by experienced scientists and business professionals to provide comprehensive regulatory compliance, quality assurance and business development services to companies in the U.S. and worldwide.
Decus BioMedical, LLC
Independent Consultants
Decus Biomedical has extensive experience supporting Class II and Class III medical device companies through all phases of development. As independent consultants, founders Grace T. Bartoo and Marc L. Bartoo and their team provide regulatory clinical trial and regulatory approval support for CPC of America, Inc.
- Grace T. Bartoo, Ph. D., RAC, CBA
Grace Bartoo is president and CEO of Decus Biomedical. With over 25 years in involvement in medical devices, she holds a Ph. D. in bioengineering and an MS in electrical engineering from the University of Washington. She is also certified in regulatory affairs (RAC) and biomedical quality auditing (CBA).
- Marc L. Bartoo, Ph. D., RAC
Marc Bartoo is technical services manager of Decus Biomedical. He holds a Ph. D. in bioengineering from the University of Washington and a B.S. in chemistry UC Berkeley. His primary expertise is in design controls, including verification and validation. Marc is also certified in regulatory affairs (RAC).
Olexander Hnojewyj, Ph.D.
Independent Consultant
Dr. Hnojewyj has extensive experience developing medical devices from concept to commercialization. Since 1995, he has served as acting Chief Technology Officer for a company developing next-generation medical devices for the treatment of vascular disease. He previously handled product development for 3M. Dr. Hnojewyj has secured multiple patents and patent applications, many of which are related to vascular closure. Dr. Hnojewyj holds a Ph.D. and Masters in Chemistry (Polymers and Coatings) from North Dakota State University and a Bachelor of Chemical Engineering from the University of Minnesota.